An Open Label, Actual Use Study in Consumers Taking an Extended-Release Over the Counter NSAID in a Naturalistic Setting
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 497
- 主要终点
- Use Days With One or More Misuse Occasions
研究概览
简要总结
The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
详细描述
Issues on adverse event data are addressed in the Adverse Event section.
The following acronyms and abbreviations were used in the results section.
- General Educational Development (GED)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self report use of Over The Counter (OTC) analgesics
- •Able to read and understand English
- •Provide written informed consent (subjects 12- 17 years of age provide written as sent and/ or parent or legal guardian provide written consent)
- •Purchase the investigational product
排除标准
- •Have participated in a study involving OTC analgesics in the last 12 months
- •They or someone else in the household work for a market research company, an advertising agency, a public relations firm, pharmaceutical company, as a healthcare professional, or as part of a health care practice
- •Have a history of known allergies to nonsteroidal anti-inflammatory drugs (NSAIDs) (i.e., Naproxen, Ibuprofen, etc) or Aspirin
- •Have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days
- •(Female subjects) are pregnant or breastfeeding
研究组 & 干预措施
Naproxen Sodium ER (BAYH6689)
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
干预措施: Naproxen Sodium ER (BAYH6689) (Drug)
结局指标
主要结局
Use Days With One or More Misuse Occasions
时间窗: 1 month
Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.
次要结局
- Number of Subjects With and Without More Than 660 mg at Least Once(1 month)
- Number of Subjects With and Without Next Dose Less Than 22 Hours Later(1 month)
- Average Daily Dose(1 month)
- Dosing Occasions With One and More Than One Tablet Taken(1 month)
- Use Days With and Without Next Dose Less Than 22 Hours Later(1 month)
- Number of Subjects With and Without More Than One Tablet Taken Per Dose(1 month)
- Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days(1 month)
- Number of Total Dosing Occasions Per Subject(1 month)
- Number of Dosing Occasions Per Subject That Exceeded 660 mg(1 month)